Pharmaceutical products are often delivered or transferred through the use of a syringe or a syringe system. Syringe systems can include a needle of known construction, thereby enabling direct delivery of the pharmaceutical product directly into a patient, e.g., through intravenous injection, or through a septum that fluidly seals a port associated with a tube set that is, or can be, fluidly connected to a patient. Alternatively, the syringe system can be provided with a blunt needle that is constructed to be inserted through a pre-pierced septum of a tube set. The syringe system can also include a luer fitment (male or female, locking or not-locking) configured to mate with a complementary luer fitment for transfer of the pharmaceutical product from the syringe system into another medical system, e.g., transfer from the syringe to a luer-activated valve associated with a tube set.
Many pharmaceutical products in the market today are provided in an ampule or cartridge. These ampules or cartridges can be configured for use with an injection device or system that is designed to be connected to the ampules or cartridges such that a medical professional can expel the pharmaceutical product from the ampule or cartridge for delivery to the patient or transfer to another medical system. One example of an ampule or cartridge is the CARPULE® system sold by Hospira, Inc., the Assignee of this application and the inventions disclosed herein.
U.S. Pat. No. 5,653,698, which is incorporated herein by reference in its entirety, provides detailed insight into the structure and operation of a pharmaceutical cartridge of the type to be used in the present invention. The cartridge system disclosed in U.S. Pat. No. 5,653,698 includes a cartridge 40 configured to retain a pharmaceutical product therein. A piston 52 is positioned within the cartridge and fluidly seals a first, open end of the cylindrical wall 44 of cartridge 40. Piston 52 is movable within cartridge 40 such that it causes the pharmaceutical product contained in the cartridge 40 to be ejected from the cartridge as piston 52 is moved toward the second end of the cartridge. A threaded rod 54 is attached to piston 52, the threaded rod 54 being constructed to threadably attach to a piston stem 62 which can be used to facilitate movement of piston 52 within cartridge 40. The second end of cartridge 40 is fluidly sealed by a pierceable diaphragm 50 which precludes the ejection of the pharmaceutical product from the cartridge so long as the pierceable diaphragm is intact.
The cartridge system disclosed in U.S. Pat. No. 5,653,698 further includes a hub 20 portion mounted on the second end of cartridge 40. Hub 20 includes a snapping sleeve portion 22 that is movably disposed over the second end of cartridge 40. Hub 20 further includes a needle cannula 18 which, when hub 20 and cartridge 40 are moved toward one another, pierces pierceable diaphragm 50 in order to provide for an egress pathway for the pharmaceutical product contained in cartridge 40.
In use, cartridge 40 of the cartridge system disclosed in U.S. Pat. No. 5,653,698 is placed into a reusable syringe holder 56 such that ampule/cartridge 40 and snapping sleeve portion 22 of hub 20 are positioned within the holder 56. Piston stem 62 is then rotated clockwise to lock ampule 40 within holder 56 and to simultaneously urge ampule 40 forward. Because hub 20 is prevented from moving forward by holder 56, this forward movement of ampule 40 causes ampule 40 and hub 20 to move toward one another, causing needle cannula 18 to pierce pierceable diaphragm 50, and thereby providing fluid communication between the interior of ampule 40 and the interior of needle cannula 18 such that movement of piston 52 will cause fluid to be drawn into or ejected from the ampule 40, depending upon the direction of movement imparted to piston 52.
Systems of the type disclosed in U.S. Pat. No. 5,653,698 can be provided with a variety of structures for delivery or transfer of the pharmaceutical product, including needles for injecting the pharmaceutical product into a patient or for injecting the pharmaceutical product into an add port associated with a drug delivery tube set of known construction. Alternatively, a male or female luer fitting (including both locking and non-locking luer fittings) can be associated with or attached to the hub for delivery of the pharmaceutical product through a medical device having a complementary luer fitting, e.g., a luer-activated valve. Also, a blunt tube can be associated with the hub for delivery of the pharmaceutical product to a medical device having a septum, e.g., a pre-pierced septum, through which the blunt tube can be urged in order to permit the contents of the cartridge to be ejected into the medical device.
Additional examples of injectors constructed for the delivery of pharmaceutical products from a cartridge can be found in U.S. Pat. Nos. 5,447,500; 5,573,514; and Des. 366,698, each of which is incorporated herein in its entirety. The foregoing examples of the background art are intended to be illustrative and not exclusive.
Accordingly, syringe systems and injectors constructed for the delivery of pharmaceutical products from a cartridge are well known in the art. While such syringe systems and injectors according to the prior art provide a number of advantageous features, they nevertheless have certain limitations. The present invention seeks to overcome certain of these limitations and other drawbacks of the prior art, and to provide new features not heretofore available. A full discussion of the features and advantages of the present invention is deferred to the following detailed description, which proceeds with reference to the accompanying drawings.